PROVIDA OB- prenatal multivitamin mineral supplement enhanced with lactobacillus casei ke-99 capsule 
U.S. Pharmaceutical Corporation

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Provida OBTM

 Supplement Facts

 Serving Size: 1 Capsule

 Amount Per Serving  % DV*

% Daily Value

for Pregnant or

Lactating Women

 Vitamin C (as Sodium Ascorbate)60 mg  67% 50%
 Vitamin D3 (Cholecalciferol)10 mcg 50% 67%
 Vitamin B1 (as Thiamine Hydrochloride)2.5 mg 208% 179%
 Vitamin B2 (Riboflavin)3.5 mg 269% 219%
 Vitamin B3 (as Niacinamide)10 mg 63% 56%
 Vitamin B6 (Pyridoxine HCl)25 mg 1471% 1250%
 Folic Acid1.25 mg 313% 208%
 Vitamin B12 (Cyanocobalamin)12 mcg 500% 429%
 Biotin300 mcg 1000% 857%
 Pantothenic Acid
 (as Calcium d-Pantothenate)
6 mg 120% 86%

 Iron
   (20 mg from Ferrous Fumarate; 20 mg from Polysaccharide Iron Complex)

40 mg 222% 148%
 Magnesium (as Magnesium Oxide)20 mg 5% 5%
 Zinc (as Zinc Oxide)10 mg 91% 77%
 Copper (as Copper Gluconate)1 mg 111% 77%
 Lactobacillus casei KE-99
 200 Billion CFU/g**
30 mg † †
 * % Daily Values are based on a 2,000 calorie intake of adults and children 12 years and older.   † Daily value not established
 **Colony-forming units (CFU) per gram at time of manufacturing

Other Ingredients: Titanium Dioxide, FD&C Blue #1, FD&C Red #40, Hypromellose, Magnesium Stearate and Microcrystalline Cellulose.

INDICATIONS: Provida OB™ is a prenatal supplement designed to improve the nutritional status of women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers. Provida OB™ may also be used to improve the nutritional status of women before conception.

CONTRAINDICATIONS: Provida OB™ is contraindicated in patients with a known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. It is also contraindicated in patients suffering from pernicious anemia as folic acid may obscure its signs and symptoms.

Ferrous Fumarate and Polysaccharide Iron Complex (PIC): All Provida products include a unique patented source of iron, e.g. Ferrous Fumarate and Polysaccharide Iron Complex (U.S. Patent No: 11/243,043 Pending). "An increase in tolerability is observed with the formulation and is believed to occur as the result of distributing the total iron content in the composition among compounds that provide iron to the patient's blood stream via two different mechanisms. The ferrous salts are readily absorbed in the upper gut, by direct dissolution and absorption of the ferrous iron by the bloodstream. However, the iron available from PIC is absorbed in the lower gut, via an active protein transport mechanism".

Clinical Studies: Picinni, L.-Ricciotti, M. 1982. Therapeutic effectiveness of an iron-polysaccharide complex in comparison with iron fumarate in the treatment of iron deficiency anemias: PANMINERVA MEDICA-EUROPA MEDICA, Vol. 24, No. 3, pp. 213-220 (July-September 1982).

Folic Acid: Folic Acid is one of the important hematopoietic agents necessary for proper regeneration of the blood-forming elements and their function. Additionally, folic acid increases jejunal glycolytic enzymes and is involved in the desaturation and hydroxylation of long-chain fatty acids in the brain. A deficiency in folic acid results in megaloblastic anemia.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

PRECAUTIONS: Folic acid in doses above 0.1 mg - 0.4 mg daily may obscure the signs and symptoms of pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive. The use of this product by immunocompromised patients or treatment of any disorder must be medically supervised by a physician.

OVERDOSE: Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300-mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted.

DOSAGE AND ADMINISTRATION: Adults (persons over 12 years of age), one (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage. Do not administer to children under the age of 12.

HOW SUPPLIED: Provida OB™ are swedish orange opaque Vcaps® capsules printed in white "US" Logo on the cap and “ProV” on the body. Packed in child resistant cap and light resistant bottle of 30 capsules (52747-0504-30). The listed product number is not a National Drug Code. Instead, US Pharmaceutical Corporation has assigned this product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

CAUTION: Rx only.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Prenatal Multivitamin & Mineral Supplement enhanced with Lactobacillus casei KE-99

Consult package literature for full prescription information. You should contact your healthcare provider for medical advice about adverse events. To report a serious adverse event, contact US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036. Marketed by US Pharmaceutical Corporation. Manufactured with Vcaps® Plus capsule shells. Store at room temperature 15° to 30°C (59° to 86°F) and dry place. Manufactured in a FDA registered facility in the USA.

Rev. 09/2022

Patent Numbers: USA: 6,797,266; 5,626,883; Mexico MX/a/2008/004461; Singapore: 200802623-9 and other countries. Vcaps® and the Vcaps® Logo are trademarks used under license.

Packaging

ProvisaOB-504

PROVIDA OB 
prenatal multivitamin mineral supplement enhanced with lactobacillus casei ke-99 capsule
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:52747-504
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE2.5 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3.5 mg
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN10 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE25 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1.25 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN0.012 mg
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.3 mg
CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID6 mg
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON40 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE20 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 mg
COPPER GLUCONATE (UNII: RV823G6G67) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION1 mg
LACTICASEIBACILLUS CASEI (UNII: SA940P2U00) (LACTICASEIBACILLUS CASEI - UNII:SA940P2U00) LACTICASEIBACILLUS CASEI30 mg
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:52747-504-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
dietary supplement06/01/2013
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
shape
size (solid drugs)19 mm
scoring1
imprint
Labeler - U.S. Pharmaceutical Corporation (079467662)

Revised: 6/2023
Document Id: 54debd99-bb68-42ed-b141-c6bdbf558394
Set id: 0ab12104-398c-4d3c-9389-0853cb77dd66
Version: 3
Effective Time: 20230614
 
U.S. Pharmaceutical Corporation